NEXAGON Greatly Reduces Venous Leg Ulcer Size

Tue, 07/13/2010 - 11:07am

CoDa Therapeutics’ lead product candidate NEXAGON achieved positive results in tissue repair in a Phase 2 clinical study in patients with venous leg ulcers. After three applications during a four-week period, NEXAGON had statistically meaningful effects on reduction in wound size and complete healing. NEXAGON is a topically applied product that down-regulates the key gap junction protein connexin43, thought to be a “master switch” in wound healing.

The Phase 2 NOVEL Study was a randomized, vehicle-controlled, double-blind, three-arm study that enrolled 98 patients at sites in New Zealand and the United States. Patients were randomized on a 1:1:1 basis to receive low- or high-dose NEXAGON or vehicle, in addition to compression bandaging (standard-of-care). Patients received three topical applications over a four-week treatment period. At the end of treatment, high-dose NEXAGON demonstrated a 69% reduction in ulcer size, while completely healing 31% of wounds (five times more than vehicle). Patients are being followed for up to 12 weeks to further evaluate ulcer healing.

In the U.S., venous leg ulcers account for the loss of 2 million working days and nearly $3 billion in treatment costs each year. Duration of treatment can last over a year in many cases, and frequently involves the use of significant healthcare resources, resulting in substantial costs for the U.S. healthcare system.

Although most wound healing studies use a 12-16 week treatment period to provide a longer time in which to show healing, NEXAGON exhibited an excellent safety profile and tissue repair in only four weeks. These results support CoDa’s previous research showing that temporarily reducing expression of connexin43 can dampen inflammatory responses and enhance healing.

NEXAGON represents a new drug, new target, and new mechanism that differentiate it from current wound healing treatments. CoDa has two open INDs and has completed one Phase 2 and two Phase 1 clinical trials in skin and eye wounds, where NEXAGON was shown to be safe and tolerable following administration to over 350 wounds on more than 125 subjects.

CoDa expects to initiate additional clinical studies of NEXAGON in patients with venous leg ulcers, and a near-term end-of-Phase 2 meeting has been scheduled with the FDA to discuss potential registration studies to support marketing approval.

Mori R, Power KT, Wang CM, Martin P, Becker DL. Acute downregulation of connexin43 at wound sites leads to a reduced inflammatory response, enhanced keratinocyte proliferation and wound fibroblast migration. J Cell Sci. 2006; 119(Pt. 24):5193.



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